Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K844203 |
Device Name |
ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403 |
Applicant |
EXCO, INC. |
P.O. BOX 1348 |
WALL,
NJ
07719
|
|
Applicant Contact |
JOHN Y CHALAKANI |
Correspondent |
EXCO, INC. |
P.O. BOX 1348 |
WALL,
NJ
07719
|
|
Correspondent Contact |
JOHN Y CHALAKANI |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 10/30/1984 |
Decision Date | 01/02/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|